Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease

Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)

This is a double-blind,randomised,placebo-controlled clinical trial.We would like to investigate the safety and efficacy of Jianpi Qinghua granule(a Chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD).

This is a double-blind,randomised,placebo-controlled clinical trial.We recruit patients that suffer from non-erosive reflux disease and then divide them into two groups:treatment group and control group.Treatment group take Jianpi Qinghua granule and half-dose omeprazole for 4 weeks,control group take a normal dose of omeprazole for 4 weeks.Finally we investigate the safety of Jianpi Qinghua granule combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD),and contrast the efficacy of Jianpi Qinghua granule with omeprazole.

Inclusion Criteria:

• Aging between 18 and 75 years, able to read and write Chinese;
• Meet the criteria of diagnosis of NERD
• GERD Q score>=8
• Meet the TCM diagnosis of syndrome of dampness-heat due to spleen deficiency
• Receiving no other treatments during the study;
• Voluntarily agreeing with the study protocol and signing a written informed consent.

Exclusion Criteria:

• Gastro-duodenal ulcer
• Infections, inflammations, or obstruction of the small or large intestine
• History of gastrointestinal cancer, or prior surgery of the stomach or intestine
• Females who are pregnant or those lacking adequate contraception
• Unwilling to sign the informed consent